Catamenial tampon-and-applicator systems referred herein to a combination of a tampon applicator and a tampon housed in the applicator, to be self-used by a user to insert the tampon into the vagina to absorb menstrual fluid to prevent leakage of the fluid from the vagina. Commercial tampons are rated by their capacity to absorb and hold a certain amount of fluid, defined by the industry standards regulating commercial labeling of the tampons, dividing them into several categories, such as “junior,” “regular,” “super,” and the like, by a standard Syngyna Absorbency test method FDA 21 CFR 801.430
However, some tampons, regardless of their rated capability to absorb and hold fluid, fail to prevent leakage before the tampon reaches its rated absorbent capacity, allowing the menstrual fluid to bypass the tampon along vaginal walls. This problem has been known as a premature leakage. Typically in the industry, the premature leakage problem has been addressed by improving various performance characteristics of the tampons, for example, the ability of the tampons to absorb menstrual fluid faster and to swell faster inside the vagina in order to prevent menstrual fluid from bypassing the tampon along the vaginal walls. However, despite such product improvements, which typically require considerable cost, most tampons will still fail to prevent premature leakage, i.e., before they become saturated with the rated amount of the absorbed liquid.
In this respect, it has been surprisingly discovered by the applicants that the instances of premature leakage can be substantially reduced by placing tampons into a certain “target” position inside a vagina. This target placement position is different from the positions typically achieved by the use of the currently marketed tampon-and-applicator systems.
This target placement position has been identified by the applicants as a “low placement positioning” because in this position, the tampon of the tampon-and-application system of the present invention is inserted into the vagina not as deep as the tampon inserted by the use of the current tampon-and-applicator systems. The low placement positioning of the tampon can be provided by the novel low placement applicators discovered by the applicants and disclosed in the patent applications (P&G case numbers 9660, 9661, 9662, 9663 and 9664) filed Jun. 4, 2004 coincidentally with the instant patent application and hereby incorporated by reference herein.
FIG. 1 is a coronal MRI image of a tampon user having a tampon in the vagina, inserted by the user using a typical commercial tampon-and-applicator system. In comparison, FIG. 2 is a coronal MRI image of a tampon user having a tampon in the vagina, inserted by the user using a tampon-and-applicator system of the present invention.
In FIG. 1, a tampon 10 is inserted substantially deeper in the vagina than a tampon 10A in FIG. 2. The deeper insertion of the tampon 10 results in deflecting of the leading end 11 of the tampon 10 by the cervix 18, specifically by the frontal area 19 of the cervix 18 (deflecting the leading end 11 of the tampon 10 to the left, as shown in FIG. 1, or to the right, depending on the anatomy of the user), and in having the leading end 11 of the tampon 10 being disposed substantially posterior of the frontal area 19 of the cervix 18.
In comparison to FIG. 1, FIG. 2 demonstrates the most preferred position of the tampon 10A according to the present invention, when the leading end 11 of the tampon 10A is disposed anterior of the frontal area 19 of the cervix 18. It should be noted, as will be disclosed in more detail below, that the “lower placement position” discovered by the applicants can include instances when the leading end 11 of the tampon 10A is slightly posterior of the frontal area 19 of the cervix 18.
However, with respect to applicants discovery of the low-placement positioning, the commonly used standard Syngina test method referenced above does not address the inventors' discovery. Further, the Syngina method does not address the positioning of the tampon in the vagina with respect to the cervix in particular to the frontal area of the cervix. Therefore, there is a need for a novel method for in vitro testing of tampon-and-applicator systems.